Comparison Between Ultrasound-Guided Genicular Nerve Phenol Neurolysis and Intra-articular Steroid Injections

Last updated: October 7, 2023
Sponsor: University of Manitoba
Overall Status: Active - Not Recruiting

Phase

4

Condition

Chronic Musculoskeletal Pain

Treatment

Intraarticular Knee Placebo

6% aqueous phenol

MethylPREDNISolone 40 MG

Clinical Study ID

NCT06000709
HS25899
  • Ages 40-80
  • All Genders

Study Summary

Genicular nerve neurolysis (GN) constitutes a relatively novel technique, whereby different chemical compounds (i.e. alcohol, phenol) are injected in close proximity to the genicular nerves of the knee joint, with the intention to exert a neurolytic effect by denaturing proteins resulting in Wallerian degeneration distal to the lesion. Based on the preliminary evidence and considering the potential benefits of the technique, we hypothesized that ultrasound-guided genicular chemical neurolysis with phenol is superior in terms of pain relief at 3 months, when compared to intra-articular steroid (IAS) injection.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Severe knee pain for more than 6 months, defined as Numeric rating scale (NRS) scoreof 6 and greater, unresponsive to conservative medical treatment
  • Radiological OA grade 2 to 4 (Kellgren-Lawrence scale)

Exclusion

Exclusion Criteria:

  • Previous total knee replacement on the index knee
  • Prior knee radiofrequency ablation on the index knee
  • Connective tissue diseases with knee involvement (e.g. rheumatoid arthritis)
  • Body mass index ≥ 40 kg/m2
  • Uncontrolled coagulopathy, defined as supratherapeutic dose of anticoagulationmedication
  • Allergy to local anesthetics
  • Unstable opioid consumption, defined as an increase >10% in dosage during the last 3months prior to recruitment.

Study Design

Total Participants: 40
Treatment Group(s): 4
Primary Treatment: Intraarticular Knee Placebo
Phase: 4
Study Start date:
October 20, 2023
Estimated Completion Date:
July 31, 2024

Study Description

This study will allow us to determine if ultrasound-guided phenol genicular neurolys is superior to intra-articular steroid injection in terms of analgesia and functional outcomes, providing a more effective and long-lasting alternative for patients with chronic knee pain secondary to osteoarthritis